Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures
Information source: University of Milan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Intervention: Bimatoprost (Drug); Latanoprost/Timolol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Milan Official(s) and/or principal investigator(s):
Luca Rossetti, MD, Principal Investigator, Affiliation: A.O. San Paolo Hospital Milan Italy
Summary
This is a data revision with a focus on 24 hour perfusion pressures of data from a previous
randomized, double masked, multicenter clinical trial.
The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost
and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched
from a nonfixed combination of latanoprost and timolol.
The main findings of the original trial had been published on Ophthalmology [2007;114:
2244-2251].
Clinical Details
Official title: Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Difference in mean diastolic and systolic perfusion pressures
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Patients diagnosed as having POAG (primary open-angle glaucoma) or ocular hypertension and
18 years or older who fulfilled the eligibility requirements detailed below and signed an
informed consent at the screening visit were included.
Two different groups of patients were potentially eligible:
1. Those patients who were controlled (IOP< 21 mmHg) on the nonfixed combination of
latanoprost and timolol (twice daily or once daily morning administration) for at
least 3 months prior to the baseline visit.
2. Patients on monotherapy either with latanoprost or timolol who were eligible for dual
therapy being not satisfactorily controlled (IOP < 21 mmHg, or, as judged by the
physician, target IOP was not reached).
Pseudoexfoliation glaucomas and patients with diabetes were not excluded.
Exclusion Criteria:
All patients in whom beta-blockers were contraindicated were excluded. Ocular Condition.
1. Closed/barely open anterior chamber angles (ACAs) or history of acute angle closure.
The ACA was viewed by means of the Goldmann 1-mirror lens. Shaffer grading was used,
and grades II, III, and IV were included. Grades 0 and I were excluded.
2. Ocular surgery or argon laser trabeculoplasty within the last 3 months.
3. Ocular inflammation/infection occurring within 3 months before the pretrial visit.
4. Neovascular glaucomas.
5. Hypersensitivity to benzalkonium chloride or to any other component of the trial drug
solutions.
6. Other abnormal ocular condition or symptom preventing the patient from entering the
trial, according to the investigator's judgement.
7. Patients on either bimatoprost or the LTFC.
8. Patients who had undergone refractive surgery. General
9. Inability to adhere to treatment/visit plan.
10. Participation in any other clinical trial (i. e., requiring in- formed consent) within
1 month before the prestudy visit. 11. Pregnancy, nursing, or, if applicable, nonuse
of adequate contraception.
12. Any drug known to affect IOP.
Locations and Contacts
Universitaets-augenklinik, Dresden, Germany
Universitaets-augenklinik, Magdeburg, Germany
Department of Ophthalmology, University of Thessaly, University Hos- pital of Larissa, Larissa, Greece
II Department of Ophthalmology, Aristotle University of Thessaloniki, Thessaloniki, Greece
Clinica Oculistica, Dipartimento di Oftalmologia-Otorinolaringoiatria, Università di Bari, Bari, Italy
Clinica Oculistica, Università degli studi di Roma, Tor Vergata, Rome, Italy
Universitäts-Augenklinik, Inselspital, University of Bern, Bern, Switzerland
Moorfields Eye Hospital,, London, United Kingdom
A.O. San Paolo, Milan, Lombardy 20142, Italy
Additional Information
Last updated: May 29, 2014
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